Thursday, March 17, 2005

Off-Label Trust

One of a series of posts about Off-Label

In a pharmaceutical context, Off-Label refers to uses of drugs that are not approved by the regulators and cannot therefore be printed on the product label or officially promoted by the drug company. More generally, it refers to any unauthorized or emergent use of a product or service. In this blog posting, I shall explore the implications of off-label for trust.

There is a regulatory process that is supposed to allow medical practitioners and their patients to trust pharmaceutical products. Under certain conditions, trust in the regulatory process (authority trust) generates trust in particular products (commodity trust). One of these conditions is strict adherence by all parties to the label.
  • Users must confine themselves to using the product as specified on the label.
  • Providers must confine themselves to promoting the product solely as specified on the label.
Whether the drug company sales force is permitted to hint at off-label uses of a given product or not, this sets up a transference in which the nudge/wink (or enforced silence) of the salesman replaces the bureaucratic authority of the FDA.

Meanwhile, samizdat off-label information may circulate in the medical community, possibly based on direct/indirect trial/error experience by medical practitioners. This is a form of network trust.

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